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Use of the Oncology Beacon ® Module and VDW
Data to Identify Variations in Treatment and Cost
     for Patients Diagnosed with Stage III/IV
                Colorectal Cancer


18th Annual HMO Research Network Conference
                 May 1, 2012

                   Debra P. Ritzwoller
  Institute for Health Research, Kaiser Permanente Colorado
Project Team

   Co-Investigators:          PMs:
   KPNW: Mark Hornbrook,      KPCO: Kimberly Bischoff
   Maureen O’Keeffe-Rosetti   KPNW: Jill Mesa
                              KPNC: Heather Clancy
   KPNC: Larry Kushi
                              Programmer/Analysts:
   KPCO: Tom Delate, Alex     KPCO: Nikki Carroll, Capp
   Menter, Jared Freml        Luckett
                              KPNW: Mike Zimmerman,
                              Karen Riedlinger
                              KPNC: Karl Huang
Background

  Gaps exists in the literature related to the utilization
   and costs of chemotherapy agents for colorectal
   cancer (CRC) patients not captured by SEER-
   Medicare data or clinical trials
  Key factors are needed
     Treatment intent (curative vs palliative)
     Use of evidence based protocols
     Dosing
     Treatment modifications and reasons for discontinuation
     Use of second-line treatment
  These data are now available from Epicare based
   Oncology Beacon® modules that now populate
   newly developed VDW infusion files
Aims


sing the wealth of cancer treatment data newly
available as a result of recent VDW infrastructure
development efforts associated with infusion and
chemotherapy utilization, in this PILOT project we…

xamine the factors associated with the receipt of
chemotherapy


xamine the variation in chemotherapy protocols and
regimens administered to patients with advanced CRC
Methods
•   Using VDW Tumor Registry and Enrollment files at KPCO,
    KPNC, and KPNW, we identified Stage III/IV CRC patients
    diagnosed in 2010 - after Beacon implementation
     First diagnosed cancer
     Survived at least 1 month after diagnosis
     21 years of age and older
•   Linked cases to
    • VDW Demographics, Diagnosis, Census, pharmacy and procedure
      files
    • Infusion files derived from the Beacon modules
•   1st line Chemotherapy ascertained within 120 days of diagnosis
• Followed cases until death, disenrollment or end of 2011
Results

• 489 cases identified
  • 46% stage III, 54% stage IV
• 47% < 65 years
• 9% Hispanic, 9% African American, 10%
  Asian
• 83% had 6 or more comorbidities
• 68% (n=335) received chemotherapy
  • 308 had identifiable chemotherapy regimens
Receipt of chemotherapy

• Was inversely related to
  • Age
  • Stage
  • Number of comorbidities (not always significant)
• Was not associated with
  • Gender
  • Race/ethnicity
  • Education (census track proxy)
Distribution of Treatment Intent
                       by Stage
           Treatment Intent       Stage III   Stage IV
ADJUVANT                            58.5%       8.1%

 PALLIATIVE - FIRST LINE            1.4%        52.8%
 CAPECITABINE (assumed Adjuvant
for stage III)                      23.8%       19.9%

NEOADJUVANT                         10.9%       4.3%

CURATIVE - FIRST LINE               4.8%        5.6%

Missing Treatment Intent            0.7%        6.8%

PALLIATIVE - AFTER FIRST LINE       0.0%        2.5%
P < .001
Distribution of Protocols
                        by Stage
            Protocol Name              Stage III   Stage IV
ONCA COLORECTAL COLON FOLFOX-6
MODIFIED - ADJUVANT - PRL105             40.8%       23.0%

CAPECITABINE                             23.8%       19.9%
ONCA COLORECTAL COLON FOLFOX-6
MODIFIED BEVACIZUMAB - PRL106            0.0%        32.9%
ONCA COLORECTAL RECTAL FLUOROURACIL
(CI) WITH RT - PRL103                    11.6%       1.9%
ONCA COLORECTAL COLON CAPOX - PRL113     8.2%        1.9%
ONCA COLORECTAL COLON FLUOROURACIL
LEUCOVORIN (ROSWELL PARK) - PRL132       4.1%        3.1%
ONCA COLORECTAL COLON CAPOX
BEVACIZUMAB - PRL114                     0.0%        6.2%
Other                                    11.6%       11.2%
 P < .001
Distribution of First-Line Regimens
                 by Stage
           Regimen             Stage III   Stage IV
FLUOROURACIL / LEUCOVORIN /
OXALIPLATIN                      39.5%       31.1%

CAPECITABINE                     23.8%       20.5%
BEVACIZUMAB / FLUOROURACIL /
LEUCOVORIN/ OXALIPLATIN          0.7%        23.6%
FLUOROURACIL                     12.9%       1.2%

CAPECITABINE/ OXALIPLATIN        9.5%        3.1%

FLUOROURACIL / LEUCOVORIN        8.2%        3.1%
BEVACIZUMAB / CAPECITABINE /
OXALIPLATIN                      0.0%        5.0%
Other                            5.4%        12.4%
P < .001
Reasons for Discontinuation
                     by Stage
                 Reason                        Stage III Stage IV
Missing Reason for Discontinuation               40.8%     30.4%
Capecitabine                                     23.8%     19.9%
Progression of disease                           2.7%      24.8%
Treatment plan completed                         18.4%     7.5%
Toxicity from treatment                          6.1%      5.6%
Patient/family preference                        4.1%      4.3%
Maximal response                                 0.0%      3.7%

Other, please note reason in progress notes      1.4%      2.5%

Current part of multi-part regimen completed     2.0%      0.0%

Co-morbidity                                     0.0%      1.2%

 P < .001
Results – Changes & Numbers


                                          Stage III    Stage IV
                                         Mean (std)   Mean (std)



 Number of changes in treatment intent    0.8 (0.4)    0.8 (0.5)


 Number of changes in protocol            0.8 (0.5)    0.9 (0.5)


 Number of different drug regimens        1.1 (0.4)    1.4 (0.7)


 Number of cycles of drug regimen         3.6 (3.0)    3.5 (2.6)
Cost Estimation by Regimen and Dose
                                Total AWP
  Patient                                                         Total AWP     Cost Per
  example                                                          Cost Per    Treatment
               Chemotherapy       Dose      Units    AWPCost       Regimen        Plan
    A       FLUOROURACIL - IVPB   2400    mg/m2/dose $    27.99

              FLUOROURACIL        648        mg      $     4.67

               LEUCOVORIN         648        mg      $    38.88

               OXALIPLATIN        137.7      mg      $ 1,974.40                 4 cycles

                                                                  $2,045.94    $8,183.75
    B          BEVACIZUMAB        453.5      mg      $ 3,247.65

            FLUOROURACIL -IVPB    2400    mg/m2/dose $    35.77

              FLUOROURACIL        828        mg      $     5.96

               LEUCOVORIN         828        mg      $    49.68

               OXALIPLATIN        176        mg      $ 2,523.56                 2 cycles

                                                                  $ 5,862.62   $11,725.24
    C
            XELODA TAB 500MG      100       caps     $   329.24   $ 3,292.37   $3,292.37
Summary of Results

• The distributions associated with treatment intent,
  protocols, regimens, and reasons for discontinuation,
  varied significantly by stage.
• The most common first line treatment was Oxaliplatin
  + Fluorouracil + Leucovorin.
• First-line oral chemotherapy agents (e.g capecitabine)
  are not always captured in Beacon
• Missing observations are common for some variables
  (e.g reason for discontinuation, treatment intent, etc)
• Costs of chemotherapy vary by both regimen and
  dosage
Conclusions

  Newly available VDW chemotherapy infusion
  data derived from the EpicCare and Oncology
  Beacon® files (along with other infusion data
  sources) is a rich cancer treatment data
  source that researchers can use to conduct
  clinical- and policy-relevant comparative
  effectiveness research studies in patients
  with colorectal cancer.
Acknowledgements


  This pilot project was directly funded by Kaiser Permanente and the
Center for Safety and Effectiveness Research (CESR). Indirect support and
 support for preliminary analyses were provided by NCI Grant No. RC2
CA148185, Building CER Capacity: Aligning CRN, CMS, and State
Resources to Map Cancer Care, Co-PIs: Jane C. Weeks, MD and Debra P.
Ritzwoller, PhD, and NCI Cooperative Agreement No. U19 CA79689,
Increasing Effectiveness of Cancer Control Interventions (Cancer Research
Network), PI: Edward H. Wagner, MD.



pecial thanks to Drs. Jane Weeks and Deborah Schrag for their comments
and suggestions regarding the original study design.

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Use of the Oncology Beacon Module and Virtual Data Warehouse Data to Identify Variations in Treatment for Advanced Colorectal Cancer RITZWOLLER

  • 1. Use of the Oncology Beacon ® Module and VDW Data to Identify Variations in Treatment and Cost for Patients Diagnosed with Stage III/IV Colorectal Cancer 18th Annual HMO Research Network Conference May 1, 2012 Debra P. Ritzwoller Institute for Health Research, Kaiser Permanente Colorado
  • 2. Project Team Co-Investigators: PMs: KPNW: Mark Hornbrook, KPCO: Kimberly Bischoff Maureen O’Keeffe-Rosetti KPNW: Jill Mesa KPNC: Heather Clancy KPNC: Larry Kushi Programmer/Analysts: KPCO: Tom Delate, Alex KPCO: Nikki Carroll, Capp Menter, Jared Freml Luckett KPNW: Mike Zimmerman, Karen Riedlinger KPNC: Karl Huang
  • 3. Background  Gaps exists in the literature related to the utilization and costs of chemotherapy agents for colorectal cancer (CRC) patients not captured by SEER- Medicare data or clinical trials  Key factors are needed  Treatment intent (curative vs palliative)  Use of evidence based protocols  Dosing  Treatment modifications and reasons for discontinuation  Use of second-line treatment  These data are now available from Epicare based Oncology Beacon® modules that now populate newly developed VDW infusion files
  • 4. Aims sing the wealth of cancer treatment data newly available as a result of recent VDW infrastructure development efforts associated with infusion and chemotherapy utilization, in this PILOT project we… xamine the factors associated with the receipt of chemotherapy xamine the variation in chemotherapy protocols and regimens administered to patients with advanced CRC
  • 5. Methods • Using VDW Tumor Registry and Enrollment files at KPCO, KPNC, and KPNW, we identified Stage III/IV CRC patients diagnosed in 2010 - after Beacon implementation  First diagnosed cancer  Survived at least 1 month after diagnosis  21 years of age and older • Linked cases to • VDW Demographics, Diagnosis, Census, pharmacy and procedure files • Infusion files derived from the Beacon modules • 1st line Chemotherapy ascertained within 120 days of diagnosis • Followed cases until death, disenrollment or end of 2011
  • 6. Results • 489 cases identified • 46% stage III, 54% stage IV • 47% < 65 years • 9% Hispanic, 9% African American, 10% Asian • 83% had 6 or more comorbidities • 68% (n=335) received chemotherapy • 308 had identifiable chemotherapy regimens
  • 7. Receipt of chemotherapy • Was inversely related to • Age • Stage • Number of comorbidities (not always significant) • Was not associated with • Gender • Race/ethnicity • Education (census track proxy)
  • 8. Distribution of Treatment Intent by Stage Treatment Intent Stage III Stage IV ADJUVANT 58.5% 8.1% PALLIATIVE - FIRST LINE 1.4% 52.8% CAPECITABINE (assumed Adjuvant for stage III) 23.8% 19.9% NEOADJUVANT 10.9% 4.3% CURATIVE - FIRST LINE 4.8% 5.6% Missing Treatment Intent 0.7% 6.8% PALLIATIVE - AFTER FIRST LINE 0.0% 2.5% P < .001
  • 9. Distribution of Protocols by Stage Protocol Name Stage III Stage IV ONCA COLORECTAL COLON FOLFOX-6 MODIFIED - ADJUVANT - PRL105 40.8% 23.0% CAPECITABINE 23.8% 19.9% ONCA COLORECTAL COLON FOLFOX-6 MODIFIED BEVACIZUMAB - PRL106 0.0% 32.9% ONCA COLORECTAL RECTAL FLUOROURACIL (CI) WITH RT - PRL103 11.6% 1.9% ONCA COLORECTAL COLON CAPOX - PRL113 8.2% 1.9% ONCA COLORECTAL COLON FLUOROURACIL LEUCOVORIN (ROSWELL PARK) - PRL132 4.1% 3.1% ONCA COLORECTAL COLON CAPOX BEVACIZUMAB - PRL114 0.0% 6.2% Other 11.6% 11.2% P < .001
  • 10. Distribution of First-Line Regimens by Stage Regimen Stage III Stage IV FLUOROURACIL / LEUCOVORIN / OXALIPLATIN 39.5% 31.1% CAPECITABINE 23.8% 20.5% BEVACIZUMAB / FLUOROURACIL / LEUCOVORIN/ OXALIPLATIN 0.7% 23.6% FLUOROURACIL 12.9% 1.2% CAPECITABINE/ OXALIPLATIN 9.5% 3.1% FLUOROURACIL / LEUCOVORIN 8.2% 3.1% BEVACIZUMAB / CAPECITABINE / OXALIPLATIN 0.0% 5.0% Other 5.4% 12.4% P < .001
  • 11. Reasons for Discontinuation by Stage Reason Stage III Stage IV Missing Reason for Discontinuation 40.8% 30.4% Capecitabine 23.8% 19.9% Progression of disease 2.7% 24.8% Treatment plan completed 18.4% 7.5% Toxicity from treatment 6.1% 5.6% Patient/family preference 4.1% 4.3% Maximal response 0.0% 3.7% Other, please note reason in progress notes 1.4% 2.5% Current part of multi-part regimen completed 2.0% 0.0% Co-morbidity 0.0% 1.2% P < .001
  • 12. Results – Changes & Numbers Stage III Stage IV Mean (std) Mean (std) Number of changes in treatment intent 0.8 (0.4) 0.8 (0.5) Number of changes in protocol 0.8 (0.5) 0.9 (0.5) Number of different drug regimens 1.1 (0.4) 1.4 (0.7) Number of cycles of drug regimen 3.6 (3.0) 3.5 (2.6)
  • 13. Cost Estimation by Regimen and Dose Total AWP Patient Total AWP Cost Per example Cost Per Treatment Chemotherapy Dose Units AWPCost Regimen Plan A FLUOROURACIL - IVPB 2400 mg/m2/dose $ 27.99 FLUOROURACIL 648 mg $ 4.67 LEUCOVORIN 648 mg $ 38.88 OXALIPLATIN 137.7 mg $ 1,974.40 4 cycles $2,045.94 $8,183.75 B BEVACIZUMAB 453.5 mg $ 3,247.65 FLUOROURACIL -IVPB 2400 mg/m2/dose $ 35.77 FLUOROURACIL 828 mg $ 5.96 LEUCOVORIN 828 mg $ 49.68 OXALIPLATIN 176 mg $ 2,523.56 2 cycles $ 5,862.62 $11,725.24 C XELODA TAB 500MG 100 caps $ 329.24 $ 3,292.37 $3,292.37
  • 14. Summary of Results • The distributions associated with treatment intent, protocols, regimens, and reasons for discontinuation, varied significantly by stage. • The most common first line treatment was Oxaliplatin + Fluorouracil + Leucovorin. • First-line oral chemotherapy agents (e.g capecitabine) are not always captured in Beacon • Missing observations are common for some variables (e.g reason for discontinuation, treatment intent, etc) • Costs of chemotherapy vary by both regimen and dosage
  • 15. Conclusions Newly available VDW chemotherapy infusion data derived from the EpicCare and Oncology Beacon® files (along with other infusion data sources) is a rich cancer treatment data source that researchers can use to conduct clinical- and policy-relevant comparative effectiveness research studies in patients with colorectal cancer.
  • 16. Acknowledgements This pilot project was directly funded by Kaiser Permanente and the Center for Safety and Effectiveness Research (CESR). Indirect support and support for preliminary analyses were provided by NCI Grant No. RC2 CA148185, Building CER Capacity: Aligning CRN, CMS, and State Resources to Map Cancer Care, Co-PIs: Jane C. Weeks, MD and Debra P. Ritzwoller, PhD, and NCI Cooperative Agreement No. U19 CA79689, Increasing Effectiveness of Cancer Control Interventions (Cancer Research Network), PI: Edward H. Wagner, MD. pecial thanks to Drs. Jane Weeks and Deborah Schrag for their comments and suggestions regarding the original study design.